Anal Sphincter Prosthesis in Treating Patients Who Are Undergoing Surgery for Anal or Rectal Cancer

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Determine the risk of complications and feasibility of total anorectal reconstruction using the Acticon Neosphincter prosthesis after abdominoperineal resection in patients with anal or rectal cancer.

Determine continence, bowel function, and quality of life of patients treated with this surgery.

OUTLINE: Patients undergo abdominoperineal resection (APR) with perineal colostomy and diverting loop ileostomy. At least 3 months after APR, patients undergo placement of the Acticon Neosphincter prosthesis. At least 6 weeks after prosthesis placement, the prosthesis is activated. When the patient demonstrates the ability to operate the prosthesis, the ileostomy is reversed.

Quality of life is assessed at 6 and 12 months and then annually thereafter.

Patients are followed at 6 and 12 months and then annually thereafter.

All patients will follow a common treatment algorithm. Anorectal reconstruction with the ABS neosphincter device will be a staged surgical approach. Routine postoperative testing will then be performed at 6 months (+/- 8 weeks) and 12 months (+/- 8 weeks), following ileostomy reversal which we have designated as time zero. Postoperative testing will include completion of a series of questionnaires.

Determine the risk of complications and feasibility of total anorectal reconstruction using the Acticon Neosphincter prosthesis after abdominoperineal resection in patients with anal or rectal cancer. [ Time Frame: 2 years ]

Secondary Outcome Measures :

Determine continence, bowel function, and quality of life of patients treated with this surgery. [ Time Frame: 2 years ]

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Subject Inclusion Criteria:

Histologically proven cancer of distal rectum or anus

Not candidates for sphincter preservation

> or = 18 years of age

an acceptable risk for surgery and general anesthesia

sufficient dexterity and mental capacity to operate the device

willing and able to give valid Informed Consent

Subject Exclusion Criteria:

Patients with recurrent anorectal cancer

Patients with metastatic anorectal cancer

Patients at high risk for local recurrence

Patients with active pelvic sepsis

Patients currently enrolled in another study involving an investigational product